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Full Text ES-96-008
NIH GUIDE, Volume 25, Number 39, November 15, 1996
RFA: ES-96-008
P.T.  34

  Community/Outreach Programs 
  Disease Prevention+ 
  Environmental Health 

National Institute of Environmental Health Sciences
Office of Behavioral and Social Sciences Research
Letter of Intent Receipt Date:  December 10, 1996
Application Receipt Date:  February 11, 1997
The National Institute of Environmental Health Sciences (NIEHS)and
the Office of Behavioral and Social Sciences Research (OBSSR) invite
research grant applications addressing development of community-based
strategies aimed at prevention and intervention activities in
economically disadvantaged and/or underserved populations adversely
impacted by an environmental contaminant.  The purpose of awards in
this program of Community-Based Prevention/Intervention Research in
Environmental Health Sciences is to:
o  Stimulate further advances in the design and implementation of
prevention and intervention methods that are appropriately applied to
environmental health.
o  Develop community-based public health research approaches to
diseases and health conditions having an environmentally related
etiology and determine the impact of these methods.
o  Bridge the gaps between basic and clinical research in
environmental health science as well as gaps between institutional
researchers and community members.
The long-range goal of this program is to improve the knowledge and
behavior of disadvantaged or underserved community members regarding
prevention, detection, and treatment of environmentally related
diseases and health conditions, and thereby reduce incidence and
mortality rates of such diseases and conditions.
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
"Community-Based Prevention/Intervention Research in Environmental
Health Sciences," is related to the priority area of Environmental
Health.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People
2000" (Summary Report: Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington
DC 20402-9325 (telephone 202-783-3238).
Applications may be submitted by public and private for-profit and
nonprofit domestic organizations, such as universities, colleges,
hospitals, laboratories, research institutions, units of state or
local governments, tribal governments or organizations, and eligible
agencies of the federal government.
Collaborative applications are invited.  Formation of a consortium
involving responsible partnership of a
research-intensive health science center and an institution serving
an economically disadvantaged community is particularly encouraged.
Among collaborators, one must be designated as the lead applicant and
assume responsibility for conduct of the project.
Because of the community-based nature of this research effort,
applicants must describe an existing or proposed involvement with one
or more community-based organizations in an area having an
underserved population adversely impacted by an environmental
contaminant (see Objectives and Scope, below).  Applications lacking
an existing or proposed link to such a community-based organization
will be considered to be nonresponsive to this RFA.
The NIEHS has a significant commitment to the support of programs
designed to increase participation of individuals from economically
disadvantaged communities in biomedical and behavioral research.
Therefore, applications from such individuals are encouraged.
The estimated funds (total costs) available for the first year of
support for this program are expected to be $1,500,000 in fiscal year
1997.  The actual amount may vary, depending on the response to this
announcement and the availability of funds.  The anticipated number
of awards is four.
Although this program is provided for in the financial plans of the
NIEHS, awards pursuant to this RFA are contingent upon the
availability of funds for this purpose.  Funding beyond the first and
subsequent years of the award will be contingent upon satisfactory
progress and fulfillment of the Special Requirements (see below)
during the preceding year and availability of funds.
This RFA will use the National Institutes of Health (NIH) exploratory
research project grant (R21) mechanism.  These grants provide support
to develop new research activities in categorical program areas,
e.g., prevention/intervention research.  Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant.
Because the nature and scope of research activities proposed in
response to this RFA may vary, it is anticipated that the size of an
award will also vary.  The maximum allowable award is $250,000 in
direct costs per year.  Indirect costs will be paid at the approved
indirect cost rate for the applicant organization less appropriate
exclusions.  The total project period for an application may not
exceed four years.
This RFA is a one-time solicitation.
This RFA, ES-96-008, is a reannouncement of RFA ES-96-005.  An
applicant who responded to the original RFA but did not receive an
award may submit a revised application based on criticisms contained
in the summary statement.  Applicants interested in submitting such a
revised application are urged to read the appropriate instructions on
page IV-5 of the PHS 398 and to contact program staff listed under
The mission of the NIEHS is to define: how environmental exposures
affect our health; how individuals differ in their susceptibility to
these effects; and how these susceptibilities change with time.  The
OBSSR provides leadership and direction in increasing the scope and
support of research on the role of human behavior and social
processes in the promotion of health and prevention of disease.
To help reduce the burden of environmentally associated diseases and
health conditions, both agencies must: 1) provide the scientific
basis and foundation that is necessary for understanding the impact
of the environment on human health; 2) translate this information
into prevention and intervention strategies; and 3) communicate this
information to the public.
The current initiative spans all three of these elements within the
missions of the NIEHS and the OBSSR.  Environmental health policy is
only as good as the scientific foundation upon which it rests.
Recent advances are enabling scientists to develop more detailed and
meaningful insights into the effects of environmental agents on basic
cellular processes.  This knowledge in turn can be used to cultivate
intervention schemes based on an enhanced understanding of molecular
mechanisms. In 1992 the NIEHS issued an RFA to develop interventions
at the molecular level for diseases with an environmental etiology.
That announcement focused on generation and use of molecular
biomarkers to assess the effectiveness of intervention strategies.
An understanding of the environmental components and basic biology of
disorders can lead to prevention and intervention strategies to
circumvent adverse health effects.  Such strategies can be classified
as primary, secondary, or tertiary prevention.  Traditionally, most
approaches have focused on primary prevention techniques aimed at
intervening before disease arises, such as eliminating or reducing
environmental exposures.  As our understanding of the molecular and
cellular basis of environmentally associated diseases increases,
secondary prevention and intervention techniques can be developed to
diagnose and treat people exposed to an environmental contaminant.
These molecular intervention techniques, such as early detection
screening, rely on manipulation of underlying biological mechanisms,
e.g., activation/inactivation of particular genes, enzymes, or
receptors.  These methods may be especially useful in dealing
with environmental exposures that are ubiquitous or difficult to
eliminate.  Tertiary prevention measures seek to limit injury and
disability in people already affected by a specific disease process.
Prevention and intervention schemes must also take into account the
social and cultural lifestyle and behavioral factors that contribute
to environmentally associated disorders.  It is part of the
responsibility of the NIEHS to provide the scientific underpinning
that can delineate the contribution of societal and cultural
behaviors in development of these disorders. The cultural diversity
inherent within various racial/ethnic groups has generally been
overlooked by investigators conducting prevention research.  Thus,
there is a critical need to address diverse, culturally relevant
contexts and disease etiologies in environmental health.
The present RFA seeks to implement culturally relevant
prevention/intervention activities in economically disadvantaged
and/or underserved populations adversely impacted by an environmental
contaminant.  Research efforts to identify the sources and effects of
hazardous environmental exposures among underserved populations have
been insufficient.  Little is known about the types of environmental
agents to which members of such groups are exposed, both at home and
at work.  Members of economically disadvantaged and/or underserved
populations suffer disproportionate levels of morbidity and
mortality.  Additionally, they are most often the populations with
the highest degree of exposure to environmental agents and are
frequently the populations with the least information available as to
the health consequences of such exposure.  Factors such as
malnutrition, health status, and socioeconomic status, in combination
with behaviors such as smoking, alcohol consumption, and drug use may
significantly influence the dose response, metabolism, and health
effects of hazardous substances.  Geographic location may also play a
role in determining the degree and effect of environmental exposure
among socioeconomically disadvantaged populations.  For example,
inner city residents often live in homes with high lead levels and
are exposed to higher levels of air pollution.  Toxic waste sites,
nuclear facilities, and chemical plants are often located in rural
areas.  More effort must be devoted to identifying disadvantaged
populations having high levels of exposure to environmental hazards
and to generating prevention and intervention strategies to mitigate
the health effects of these hazards.
The current announcement is intended not only to foster additional
refinement of intervention methods but also to strengthen the
participation of affected communities in this effort.  Given the
complexity and magnitude of environmental health problems, research
endeavors aimed at improving our knowledge of and ability to resolve
these issues can benefit from establishing collaborative
relationships with the communities experiencing these problems.  Such
community-research partnerships have benefits for both the researcher
and the community.  These partnerships can, for example, facilitate
the definition of important environmental issues and concerns, the
development of measurement instruments that are culturally
appropriate, and the establishment of trust that will enrich the
value of data collected.  This scheme emphasizes the involvement of
community members throughout the research process, from development
of research questions to interpretation, application, and
dissemination of results.  Only through realization of this final leg
of the NIEHS mission, i.e., communication and partnership formation,
can we ensure that research findings reach and are made relevant to
affected individuals and communities.
Objectives and Scope
This RFA will support research activities that develop and implement
improved prevention and intervention strategies related to
environmental health that are designed to include community-based,
culturally appropriate approaches applicable to underserved
populations.  Community-based
prevention/intervention research seeks to expand our knowledge and
understanding of  the potential causes and remedies of
environmentally related disorders, while at the same time enhancing
the capacity of communities to participate in the processes that
shape research approaches and intervention strategies. Community-
based research is thus more than just a community-placed outreach
activity.  These research projects are community-driven and -
responsive so as to maximize the potential for change in knowledge,
attitudes, and behavior.  They are conducted in a manner that
reinforces collaboration between community members and research
institutions.  Relevant results from these projects are disseminated
to the community in clear, useful terms.  Moreover, these studies are
designed to be culturally appropriate, i.e., due consideration is
given to the social, economic, and cultural conditions that influence
health status.  Identifying and incorporating unique cultural factors
into intervention strategies may result in increased acceptability,
use, and adherence.
Each application should develop a comprehensive, strategic plan with
time schedules and milestones to address all key aspects.  This plan
should include:
o  Identification of target community.  Population(s) should be
clearly identified, community boundaries described, and known
environmental health hazards delineated.
o  Community collaboration.  How will communication and regular
exchange of information and ideas between community members and
institutional researchers be initiated and enhanced?  How are
productive relationships with local representatives established and
maintained?  How are local organizations and leaders recruited?  What
are the mechanisms for communities to identify their environmental
health needs?  How will activities be designed to meet these needs?
How will findings be disseminated within the community?
o  Research program definition and implementation.  A variety of
research designs may be proposed (see below).  Primary, secondary, or
tertiary prevention strategies may be included.  Interventions should
be based on appropriate behavioral and scientific theories.  They
should also be built on the results of previous methods shown to be
efficacious in changing risk factors related to knowledge, attitudes,
and behaviors.  Interventions should use multiple, culturally
sensitive, community-based approaches and be adapted to the special
needs of underserved populations.
o  Evaluation.  Both outcome and process evaluations should take
place.  Only projects having well developed, comprehensive evaluation
plans will be supported.  The application must include detailed
descriptions of process and outcome evaluation, specify the measures
and instruments for data collection, and indicate a time frame for
conducting all evaluation activities.
Research designs should focus on an integrated approach employing
various culturally appropriate factors that have been previously
shown to be effective.  It is important that the study population be
clearly identified and that community involvement in developing the
design be demonstrated.  An experimental design with a defined
hypothesis is the preferred approach.  A randomized design, comparing
specially constructed interventions in an experimental cohort against
usual and customary conditions in a control cohort, would be an
appropriate study design to test intervention models.  Other designs
may also be considered responsive.  Elements that should be
considered in assembling such a research design include:
o Conceptual framework.
o Sampling procedures.
o Instrumentation and measurement.
o Data collection.
o Quality control and process evaluation.
o Recruitment, retention, tracking, and follow-up.
o Data analysis, statistical methods, and power considerations.
State-of-the-art econometric techniques for measuring
cost-effectiveness of prevention efforts may also be included.
Applicants are encouraged to test and compare multiple innovative
strategies and to assess their relative effectiveness.
In community-based research, active cooperation and participation of
organizations within the community(ies) that is (are) the focus of
the study are essential components of the research.  Hence,
applicants must describe an existing or proposed involvement with one
or more community-based organizations in an area having an
underserved population adversely impacted by an environmental
contaminant.  This connection is essential to the development of
community-based approaches and should also enhance the potential for
long-term impact of the project.  Strengths of this approach are its
incorporation of local knowledge and beliefs and the possibility of
positioning local people as owners and implementors of the
intervention.  The result should be an intervention tailored to the
specific concerns, needs, and interests of the local community.
Community input is most meaningful and best utilized if it is built
into the research process from the outset.  Community representatives
should be given a voice in choosing research topics, developing the
application, collecting data, and interpreting results.  For this
reason, applications lacking an existing or proposed link to a
community-based organization will be considered to be nonresponsive
to this RFA.
Annual meetings, to be held in Research Triangle Park, NC, are
planned for the exchange of information among investigators.
Applicants must budget travel costs associated with these meetings in
their applications.  Since projects may include behavioral based
prevention/intervention strategies as part of their methodology, the
Office of Behavioral and Social Sciences Research will contribute to
this initiative by co-sponsoring these conferences.
In addition, since these projects are community-based, applicants are
expected to maximize opportunities for information exchange between
institutional researchers and community members.  As part of this
program, applicants must generate a report that describes community
input, program implementation, and relevant findings.  This report
must be produced at least annually and distributed among community
members in such a way that it can be easily comprehended by the
public.  Applicants must budget for production and dissemination of
such reports.  This requirement is intended to establish a minimal
level of communication among project participants; additional, more
frequent dissemination efforts may be appropriate.
Activities conducted under this announcement should be consistent
with Federal Executive Order No. 12898 entitled, ~Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations.~  To the extent practicable and permitted by law,
grantees shall make achieving environmental justice part of their
project~s mission by identifying and addressing, as appropriate,
disproportionately high and adverse human health effects of
environmental contaminants on minority and low-income populations.
The current RFA builds upon the framework established by the separate
NIEHS grant program entitled ~Environmental Justice: Partnerships for
Communication.~  That program, initiated in 1993, supports outreach,
training, and education efforts that will become the catalyst for
reducing exposure to environmental pollutants in socioeconomically
disadvantaged or underserved populations.  Its main objective is to
establish methods for linking members of a community, who are
directly affected by adverse environmental conditions, with
environmental health researchers and health care providers.  This
endeavor will help to ensure that the community is aware of basic
environmental health concepts and that they have a role in defining
problems and shaping approaches to their solution.
The present RFA differs from the ~Environmental Justice~ grant
program in that the former is a scientific research project, whereas
the latter is an education project.  Thus, this RFA is intended to
support specific, rigorous, scientific research projects that develop
and implement community-based, culturally appropriate
prevention/intervention strategies in underserved communities.  The
~Environmental Justice~ program supports education projects that
enhance the flow of information and communication among scientists,
health care providers, and community members.  Although these
programs are complementary, it is important to differentiate the
substantial research orientation of this RFA from the educational
goal of the ~Environmental Justice~ program.
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 9, 1994 (FR 58 11146-11151) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information should be included in the form PHS 398
in Sections A-D of the Research Plan and summarized in Section E,
Human Subjects. Applicants are urged to assess carefully the
feasibility of including the broadest possible representation of
minority groups.  However, NIH recognizes that it may not be feasible
or appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority populations
(i.e., Native Americans (including American Indians or Alaskan
Natives), Asian/Pacific Islanders, Blacks, Hispanics).  The rationale
for studies on single minority population groups should be provided.
The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.
If the required information is not contained within the application,
it will be returned to the applicant.
Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.
NIH funding components will not award grants or cooperative
agreements that do not comply with these policies.
Prospective applicants are requested to submit, by December 10, 1996,
a letter of intent that includes a descriptive title of the proposed
project, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.  The letter of intent
influences neither review nor funding decisions, but it is helpful to
NIEHS staff in planning the review process, e.g., in estimating
workload and avoiding conflict of interest.
Letters of intent should be directed to:
Allen Dearry, Ph.D.
Chemical Exposures and Molecular Biology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD 3-04
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email:  ASKNIH@odrockm1.od.nih.gov.
The RFA label available in the 5/95 revision of the PHS 398
application form must be affixed to the bottom of the face page of
the application.  Failure to use this label could result in delayed
processing of the application such that it may not reach the review
committee in time for review.  In addition, the RFA title and number
must be typed on line two of the face page of the application form
and the YES box must be marked.
Submit a signed, typewritten original of the application, including
the checklist, and three signed, photocopies, in one package to:
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
Ethel Jackson, D.D.S.
Chief, Scientific Review Branch
Division of Extramural Research & Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD 17-09
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Applications must be received by February 11, 1997.  If an
application is received after that date, it will be returned to the
applicant without review.  The Division of Research Grants (DRG) will
not accept any application in response to this RFA that is
essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The DRG will not
accept any application that is essentially the same as one already
reviewed.  This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications
must include an Introduction addressing the previous critique (see
All human and animal welfare as well as misconduct assurances must be
complete for a proposal to be reviewed.  All follow-up assurances and
approvals submitted as pending must be received within 30 days of the
application receipt deadline or the application will not be reviewed.
The following is the schedule planned for this initiative.  It should
be noted that this schedule may be changed without notification due
to factors that were unanticipated at the time of the announcement.
Please contact the program official listed below regarding any
changes in the schedule.
RFA Announcement: November 8, 1996
Receipt of Letters of Intent: December 10, 1996
Application Receipt Deadline: February 11, 1997
Initial Scientific Review: March, 1997
Advisory Council Review: May, 1997
Funding: July, 1997
Review will be carried out by the Scientific Review Branch, Division
of Extramural Research and Training.  Upon receipt, applications will
be screened for completeness by staff of the DRG and for
responsiveness to the RFA by staff of the NIEHS.  Those that are
incomplete or nonresponsive will be returned to the applicant without
review.  Complete and responsive applications will be reviewed by
either the Environmental Health Sciences Review Committee or a
special review committee impaneled by the Scientific Review Branch.
As part of the initial merit review, all applications will receive a
written critique and undergo a process in which only those
applications deemed to have the highest scientific merit, generally
the top half of applications under review, will be discussed,
assigned a priority score, and receive a second level review by the
National Advisory Environmental Health Sciences Council and/or the
National Advisory Council for Nursing Research.
The major review factors listed below will be used in evaluation of
applications for this RFA:
o  Scientific, technical, or clinical significance, merit, and
originality of the proposed research.
o  Appropriateness, adequacy, and feasibility of the proposed
approach and methodology.  If applicable, sample size, recruitment,
and retention plans should be discussed.  Extent to which the design
demonstrates sensitivity to cultural and socioeconomic factors in the
o  Extent of community sanction/liaison.  Rationale for selection of
the targeted population and documentation of environmental health
needs and risk factors.  Evidence of access to, interaction with, and
participation of community members and community leaders in
development and conduct of the project.  Establishment of
collaborative interactions among all project participants.
Demonstration of effective communication channels between researchers
and community members.  Plans for useful and practical dissemination
of project activities and findings within the affected
community(ies).  Active involvement of at least one community-based
organization is a minimal requirement for responsiveness to this RFA.
o  Qualifications and experience of the principal investigator and
staff.  Personnel should demonstrate knowledge of the needs of their
target audience.
o  Strength of institutional commitment as evidenced by provision of
resources, services, technical support, and allocation of space
necessary to perform the research.
o  Appropriateness of proposed budget and duration in relation to the
project's objectives.
o  Adequacy, appropriateness, feasibility, and comprehensiveness of
the evaluation plan, including sufficient allocation of resources.
o  Feasibility of plans for independently continuing the program.
Evidence of continuing commitment on the part of the proposing
institution(s).  The potential long-term impact of the proposed
project is especially important.
o  The initial review group will also examine provisions for
protection of human subjects.
The following will be considered in making funding decisions:
o  Merit of the application as determined by peer review.
o  Availability of funds.
o  Program balance among research areas of the NIEHS.
NIEHS staff welcome the opportunity to clarify any issues or
questions from potential applicants.  Written or telephone inquiries
concerning the objectives, scope, application procedures, and
submission of revised applications for this RFA or inquiries about
whether or not specific proposals would be responsive are encouraged
and should be directed to the following:
Allen Dearry, Ph.D.
Chemical Exposures and Molecular Biology Branch
National Institute of Environmental Health Sciences
Division of Extramural Research and Training
P.O. Box 12233, MD 3-04
Research Triangle Park, NC  27709
Telephone: (919) 541-4500
FAX:  (919) 541-4937 or (919) 541-2843
Questions of an administrative or fiscal nature not directly related
to the programmatic aspects of this RFA should be directed to the
Grants Management Branch official listed below:
Ms. Carolyn Winters
Grants Management Specialist
Grants Management Branch
National Institute of Environmental Health Sciences
Division of Extramural Research and Training
P.O. Box 12233, MD 2-01
Research Triangle Park, NC  27709
Telephone: (919) 541-7823
FAX:  (919) 541-2860
This program is described in the Catalog of Federal Domestic
Assistance Number 93.113, 93.114 and 93.115.  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public Law 100-607) and administered under PHS grant policies and
Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.  The program
is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or, in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

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